Director, Product Release
Grifols
full-time
Posted on:
Location Type: Office
Location: NC-RTP • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Responsible for the final release of plasma to Grifols Manufacturing and all 3rd party customers requesting plasma from the US Plasma Logistic Centers.
- Ensure the release of plasma for the further manufacturing of medicinal products is in accordance with all US and European regulations.
- Review and ensure compliance with all Quality Agreements established between Grifols Worldwide and manufacturing customers.
- Oversee activities and provide leadership to the team responsible for management of supplier quality to ensure suppliers meet the standards set forth by procedures and regulations.
- Lead a team that manages supply and supplier qualifications, deviations, defective soft goods, investigations, quality agreements and general interactions with 3rd party suppliers and vendors.
- Review and ensure compliance with all Quality Agreements established between Grifols Worldwide and plasma suppliers.
- Responsible for managing the Grifols Plasma Quality Database (PQD) used to manage the plasma donor centers, plasma testing laboratories, plasma storage locations, and plasma refrigerated carriers.
- Oversee the quality operations of the US Grifols Plasma Logistic Centers.
- Develop, author, review, and approve standard operating procedures used by the US Grifols Plasma Logistic Centers.
- Assess skills, knowledge, and abilities of candidates to make effective hiring decisions and identify developmental needs of staff members, including training, disciplinary action and performance management processes.
- Regularly examine quality systems, processes and procedures as it relates to the US Plasma Logistic Centers for increased efficiency and/or increased quality assurance as necessary.
- Act as liaison with quality/regulatory counterparts in international and domestic corporate positions, ensuring programs, systems, software are symbiotic in nature and in compliance with product release requirements for the US Plasma Logistic Centers.
- Oversee internal and external audits of quality systems within US Plasma Logistic Centers.
- Act as liaison with external domestic and international auditors.
- Acts as Subject Matter Expert in projects involving US Plasma Logistics Centers and product release.
Requirements
- A Bachelor's Degree in a medical or biological science
- Master’s degree is preferred
- A minimum of 10 years’ practical post-graduate experience in collecting and/or testing, preparing, storage and distribution of human blood and blood components
- Experience managing employees strongly preferred
- Demonstrated experience in analyzing data to make individual and/or large-scale decisions
- Experience with initiating and implementing change.
Benefits
- medical
- PTO
- up to 5% 401K match
- tuition reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
plasma releasequality assurancecompliance managementdata analysisstandard operating proceduressupplier qualificationquality systemsauditingdefective goods managementinvestigations
Soft skills
leadershipteam managementeffective hiring decisionsperformance managementcommunicationinterpersonal skillsproblem-solvingchange managementtrainingdisciplinary action